Generic drug of Xatral LP
Therapeutic class: Urology nephrology
active ingredients: Alfuzosin
laboratory: Sanofi-Aventis France
Box of 30
All forms
Indication
· Treatment of functional symptoms of benign prostatic hypertrophy.
· Adjunctive bladder catheterization in acute urine retention related to benign prostatic hypertrophy.
Dosage ALFUZOSINE LP ZENTIVA 10 mg prolonged release tablet Box of 30
Oral way.
The tablet should be swallowed whole with a glass of water. (see section 4.4 Special warnings and precautions for use ).
The recommended dosage is 1 10 mg tablet daily, to be taken immediately after the evening meal.
Adjuvant bladder catheterization in acute urine retention related to benign prostatic hypertrophy:
The recommended dosage is 1 10 mg tablet daily, to be taken after the meal, from the first day of urethral catheterization.
The treatment is administered for 3 to 4 days including 2 to 3 days during the catheterization and 1 day after the withdrawal of the latter.
Against indications
This product should not be administered in the following situations:
Hypersensitivity to alfuzosin and / or any of the other ingredients;
· orthostatic hypotension;
· Hepatic insufficiency;
· Severe renal impairment (creatinine clearance <30 ml / min);
· Combination with potent CYP3A4 inhibitors (see section Interactions with other medicinal products and other forms of interaction ).
Side effects Alfuzosine LP Zentiva
Adverse reactions are classified by frequency of occurrence using the following rule: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1 / 100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000), frequency unknown (can not be estimated from available data).
FREQUENCY | ||||
ORGAN SYSTEM | Frequent (≥ 1% - <10%) | Rare (≥ 0.1% - <1%) | very rare (<0.01%) | Not determined |
Heart conditions | tachycardia, palpitations | angina pectoris in patients with a history of coronary artery disease | atrial fibrillation | |
Eye disorders | intraoperative flaccid iris syndrome | |||
General disorders and administration site conditions | Asthenia, discomfort | edema, chest pain | ||
Gastrointestinal disorders | nausea, abdominal pain | diarrhea, oral dryness | vomiting | |
Hepatobiliary disorders | hepatocellular damage, hepatic cholestasis | |||
Nervous system disorders | dizziness, dizziness, headache | dizziness, syncope, drowsiness | ||
Disorders of reproductive organs and breast | priapism | |||
Respiratory, thoracic and mediastinal disorders | nasal congestion | |||
Skin and subcutaneous tissue disorders | rashes, pruritus | urticaria, angioedema | ||
Vascular disorders | orthostatic hypotension, flush | |||
Blood and lymphatic system disorders | neutropenia | |||
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.
